FDA 510(k) Application Details - K955381

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K955381
Device Name	Injector And Syringe, Angiographic
Applicant	B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. BETHLEHEM, PA 18018 US Other 510(k) Applications for this Company
Contact	MARK S ALSBERGE Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1995
Decision Date	02/21/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review